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$144k–$206k/yr
Full-time
bachelor degree, postgraduate degree
Medical insurance, Dental insurance, Vision insurance, Paid time off, 401k match, Life insurance
Posted 44d ago
~40 hrs/week
Responsibilities
The Regulatory Affairs Lead is responsible for developing and executing regulatory strategies for new assignments and managing complex submissions to health authorities. They act as a key regulatory expert for project teams, ensuring compliance with FDA and ICH regulations while influencing corporate strategy.
Requirements
Candidates must possess a bachelor's degree in a scientific discipline and at least 9 years of pharmaceutical drug development experience. Expertise in regulatory aspects of drug development, specifically with FDA and ICH guidelines, is required, with oncology experience preferred.
Full job description
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.
Are you driven to make a real difference in the lives of patients?
We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
Purpose and Scope:
This position plays a key role in the regulatory affairs department. Responsible for developing regulatory strategy for new assignments outside of existing regulatory frameworks (e.g., NDA strategy/planning for NMEs), with management oversight; driving submission related activities and successfully executing regulatory strategies.
Responsibilities and Accountabilities:
Actively seeks out knowledge of overall corporate strategy and other general factors that affect the regulatory positions taken within the company, and with the FDA and global health authorities, and incorporates this knowledge in interactions with others. Will also impact corporate strategy directly by participating in global strategic planning within therapeutic area project teams.
Provides regulatory expertise for New Product Planning and Licensing due diligence activities.
Member of important project teams/task forces requiring the interpretation of applicable FDA/ICH regulations to ensure compliance.
Sets direction for key operations and new initiatives. Works closely with other individuals/groups within Regulatory Affairs to influence others to ensure departmental consistency and identifies options for risk discussions.
Oversees submissions and compiles complex, strategic submissions for assigned projects. Ensures that the compilation and transmission of submissions are within the defined time schedules and meet established standards and SOPs.
Is considered a regulatory expert by global project teams/task forces and is accountable for developing and recommending regulatory strategy. Recognized as a person to whom others within the organization can consult to obtain answers to complex questions regarding FDA regulations and guidances.
Manages the preparation and review of registration packages to ensure effective data presentation and quality scientific data against regulatory requirements. Independently manages complex technical documents for preparation, review and submission to regulatory agencies.
Interacts with FDA and global health authorities on project related communications, including facilitating Divisional and committee meetings such as Pre-IND, IND, Pre-NDA, and NDA meetings. Interacts with other companies such as contract manufacturers, external development partners, and other subsidiaries.
Assists with ongoing training of Regulatory Affairs staff. Recognized as a person to whom others within the organization can consult to obtain answers to complex questions regarding FDA regulations and guidelines.
Qualifications
Required Qualifications:
Bachelor’s degree in scientific discipline; advanced degree preferred.
9 years previous pharmaceutical drug development experience
Recognized as an expert in regulatory aspects of pharmaceutical drug development involving undefined frameworks with technical complexity and broad scope.
Scientific knowledge in chemistry, general biological/physical science and ability to apply that knowledge to regulatory issues and product development. Recognized as an expert in an aspect of pharmaceutical drug development.
Strong organizational skills with the ability to manage large projects and provide regulatory guidance/training to direct reports and others in the department as needed.
Ability to communicate effectively and maintain effective working relationships. Must be able to positively influence department staff and cross-functional teams.
Preferred Qualifications:
Oncology experience strongly preferred
6 years regulatory affairs experience preferably involving direct contact with the FDA. Full knowledge of FDA and ICH regulations and guidelines, and the ability to provide interpretations of that information to others.
Proven record of successful IND/NDA submissions and negotiations with the FDA.
Global submission experience strongly desired
Location and Working Environment
This position is based in Northbrook, IL. Remote work from anywhere in the US is available.
At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
What awaits you at Astellas?
Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide. Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
Our Organizational Values and Behaviors
Values:Innovation, Integrity and Impact sit at the heart of what we do.
Behaviors: We come together as ‘One Astellas’, working with courage and a sense of urgency. We are outcome focused and consistently take accountability for our personal contribution.
Salary Range
$144,060 - $205,800 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)
Benefits:
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Company fleet vehicle for eligible positions
Referral bonus program
#LI-SS
Related keywords
Regulatory AffairsOncologyFDAICHNDAINDDrug DevelopmentPharmaceuticalComplianceSubmissionStrategic PlanningLife SciencesRegulatory StrategyProject ManagementTechnical DocumentationClinical Development
Astellas is committed to turning innovative science into VALUE for patients.
Industry
Pharmaceutical Manufacturing
Company size
10,001+ employees
Headquarters
Chuo-Ku, Tokyo
LinkedIn followers
736,122
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Visit our Global Astellas LinkedIn Community Guidelines to learn more about interacting with this page: https://www.astellas.com/en/global-linkedin-community-guidelines
Offices: 2-5-1, Nihonbashi-Honcho, Chuo-Ku, Tokyo 103-8411, JP
Pharmaceuticals and 医薬品Health CareBiotechnologyMedical
How many Healthcare jobs are open in Northbrook, IL right now?
There are currently 197 open healthcare positions in Northbrook, IL listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Northbrook, IL?
Companies currently hiring include Astellas Pharma, Covenant Living Communities and Services, USA Vein Clinics, Vascular, Fibroid and Oncology Centers, CovenantCare At Home, Compass Health Center, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Northbrook, IL?
Yes — 32 of the 197 open healthcare positions offer remote or hybrid work (9 remote, 23 hybrid).
How do I apply for Healthcare jobs in Northbrook, IL?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.